BSRBR: news
New anti-tnf comparison cohort is now open - contact the BSRBR if you have any queries/problems
Email: Biologics.Register@manchester.ac.uk
A new anti-TNF comparison cohort is now open, which is recruiting patients who are anti-TNF naive and are starting one of the established anti-TNF therapies (i.e. etanercept, adalimumab or infliximab) recruited across the UK to provide a contemporary comparison group to assess the safety profile of newly available biologic agents. The recruits must have a diagnosis of RA, be biologic naive before registration, and be registered with the BSRBR within six months of starting therapy. These participants will count towards the recruitment figures uploaded every month on the UK CRN Portal.
Only centres named as "comparison cohort recruiting centres" will be able to recruit to this cohort of the BSRBR. If you think you would like to be involved with this part of the study, please contact Katy Mowbray: Katy.Mowbray@manchester.ac.uk who will be happy to help you with gaining local ethical approval to recruit patients to this cohort.
This cohort was approved as part of the certolizumab amendment - if your Trust has already approved this amendment then you are already eligible to be a comparison cohort recruiting centre; just send the details of your centre to Katy and she will ensure that you are contacted. Click here for further information about the new cohort.
Please continue to register your patients starting Certolizumab or Tocilizumab - contact the BSRBR if you have any queries/problems
Email: Biologics.Register@manchester.ac.uk
The BSRBR is recruiting patients starting certolizumab or tociluzumab. This includes patients already registered with BSRBR who are switching to these drugs as well as patients who have not been registered with BSRBR in the past because they started etanercept, infliximab or adalimumab after the BSRBR had completed recruitment of these agents (May 2005 onwards). Baseline data collection and follow up will be the same as for the current anti-TNF therapy patients, although the choice of forms will differ based on whether or not patients are already registered.
PATIENTS SWITCHING TO CERTOLIZUMAB or TOCILIZUMAB who are already with the register need:
HAQ & EQ-5D
PATIENTS NEW TO THE BSRBR need:
Consultant baseline questionnaire
HAQ & EQ-5D
Click here for flow charts showing the above, here for a certolizumab/tocilizumab flyer
and click here to access all of the certolizumab/tocilizumab forms needed.
Recruitment to the rituximab cohort of the BSRBR will close on 31/10/2011
We will continue to accept baseline registration forms for participants starting rituximab until the end of 2011.
Please register all eligible participants before the end of the year.
Thank you for helping us reach our target for this cohort! Click here for a flyer!
*All BSRBR Follow-up Extended*
Importance of Follow-up Data (including deaths)
Ethical approval has been received to extend the consultant questionnaire follow-up of all patients to the end of the study. This means that we will be able to collect longer term safety data on important serious adverse events such as myocardial infarction and stroke. If important drug therapy data or details relating to a serious adverse event are missing, it will often result in data being excluded from forthcoming BSRBR analyses. This information is especially important if a patient has passed away. Although we are informed if a patient has died via the NHS-IC (national death register) , we do not receive any information on whether or not the patient was receiving a biologic drug at time of death. We understand that this information can be very difficult to access but it is extremely important that we receive all biologic therapy details on the follow up forms.
Rapid Faxes and Events of Special Interest Forms (ESIs):
We have now replaced our 'Rapid Fax' forms with more appropriately named 'Events of Special Interest' (ESI) forms. These forms ask for more specific information regarding certain events, including some that we have not asked for before (such as pulmonary embolism). Copies of ESIs have now been sent out to all hospitals and are also available on the website in the Health professionals section under Questionnaires and forms.
MREC amendments now online:
We have added all of the MREC substantial amendments to our website so that you can download them immediately and also be assured that you have all of the most up to date MREC information regarding the BSRBR. Please be sure to inform your R&D department of any changes.
For further information see: MREC documents
Group authorship list of contributors has now been added to the BSRBR website -
see the Full Authorship List in the Health professionals section.
This is a list of all rheumatologists/nurses/health professionals who have contributed data to the BSRBR since it started in 2001 (whether it be one or 100 patients!). This will enable BSRBR to include this group authorship in any future publications. We would urge you to check that your name is on the list if you have been involved with BSRBR work. To add details please download and complete the BSRBR Authorship form and return it to the BSRBR offices.
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